Kornimate/medical-research-clean huggingface dataset:
to evaluate the safety and initial efficacy of stsa-1002 injection in patients with acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: to evaluate the safety and initial efficacy of stsa-1002 injection in patients with acute respiratory distress syndrome.


Eligibility criteria:
inclusion criteria: 1. 18 years old≤age≤85 years old; 2. pathogen results indicate respiratory viral infection; 3. acute respiratory distress syndrome (ards) caused by viral pneumonia; 4. in 14haode days since the onset of respiratory infective symptoms (in 12 days for non-invasive mechanical ventilation patients); 5. pao₂/fio₂ ≤200 mmhg based on arterial blood gas analysis prior to randomization; 6. most recent peripheral blood lymphocyte count ≤0.8×10\^9/l prior to randomization; 7. patients (including patients' partners) has no plans for conception during the study period and within 4 months following the last dose, and agrees to use appropriate and effective contraception (e.g., birth control pills, condoms); 8. willing to participate in the study and signs the informed consent form exclusion criteria: 1. use of ecmo before the first administration; 2. more than 48 hours of invasive mechanical ventilation prior to the first dose; 3. based on the researchers' overall assessment, the patient's condition improved within the first 48 hours prior to the initial dosing (predictable improvement in oxygenation indicators observed within the next 48 hours); 4. expected survival period of less than 24 hours or a history of cardiac arrest within 4 weeks prior to screening; 5. recent history of stroke or acute coronary syndrome; 6. diagnosed with fungal pneumonia (aspergillus, mucor, cryptococcus, or pneumocystis jirovecii pneumonia); 7. suspected or known cytomegalovirus infection; 8. suspected or known active tuberculosis; 9. experienced prolonged fluid resuscitation-resistant septic shock. 10. severe chronic respiratory failure; 11. deemed by the investigator as difficult to wean from ventilation due to severe underlying diseases; 12. cardiogenic pulmonary edema or congestive heart failure; 13. liver dysfunction; 14. severe renal impairment or long-term dialysis; 15. immunocompromised state; 16. a absolute neutrophil count is excessively low; 17. severe anemia or active bleeding; 18. poor compliance with standard treatment; 19. pregnant or breastfeeding women; 20. participated in a clinical trial of a new drug and received treatment within 3 months prior to screening; 21. any condition that the investigator believes may increase the risk to the patient or interfere with the execution of the clinical trial; 22. known allergy to any component of the investigational drug or its excipients, or a history of hypersensitivity (e.g., allergic to two or more drugs); 23. any other disease or condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study;
post-operative quality of life after aaa management: evar versus open repair

Conditions: Post Operative Quality of Life After AAA Surgery

Summary: the treatment of aaa has been revolutionised by minimally invasive techniques that allow patients to return home more quickly and have a reputation for having a low impact on their quality of life. however, no study has looked at the quality of life of patients treated for aaa using open or endovascular surgery, using a scale adapted to post-operative follow-up. the investigators conducted a single-centre prospective observational study to assess the quality of life of patients undergoing aaa surgery by endovascular exclusion or open surgery

aneurysms of the abdominal aorta are common in patients over the age of 65. treatment methods to prevent rupture have changed considerably since the 2000s, with the advent of minimally invasive endovascular techniques. these minimally invasive techniques, which have the reputation of enabling patients to return home quickly without any loss of quality of life, have been called into question over time by the appearance of secondary endoleaks, leading to re-interventions and significant secondary ruptures. open aortic surgery is often described as invasive and burdensome for patients, with a lasting result in terms of efficacy in treating aaa, but at the cost of a major deterioration in patients' quality of life. the literature presents numerous studies of postoperative quality of life, using general scales that have not been validated specifically for postoperative use. furthermore, all these studies do not take into account the patient's pre-operative state and are therefore unable to provide an objective view of changes in quality of life and post-operative recovery after open surgery or evar. the qor15 is a questionnaire comprising 15 questions specifically validated for the study of patients' early postoperative recovery. in order to obtain objective data, the investigators conducted a single-centre prospective observational study to assess the quality of life of patients undergoing aaa surgery by endovascular exclusion or open surgery

Eligibility criteria:
inclusion criteria: * aortic abdominal aneurysm above 50mm exclusion criteria: * emergent surgery
a study to access the efficacy and safety of meloxicam in patients with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: to access the efficacy and safety of meloxicam 7.5mg once daily over a treatment period of 56 days


Eligibility criteria:
inclusion criteria: - osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (nsaids) exclusion criteria: none
effect of ticagrelor on endothelial function

Conditions: Coronary Artery Disease; Endothelial Function

Summary: this study is to assess the function of blood vessels while being treated with different types of blood thinners to determine the effect of these medications on blood vessels.


Eligibility criteria:
inclusion criteria: 1. age\>18 years old 2. at least two cardiovascular risk factors 3. demonstrated endothelial dysfunction 4. evidence of coronary artery disease exclusion criteria: 1. second (ii) or third (iii) degree heart block without a pacemaker 2. known active pathological bleeding, history of stroke, or bleeding diathesis 3. dyspnea classified as nyha class iii-iv 4. need for oral anticoagulants 5. clinically significant valvular heart disease 6. any concurrent life threatening condition with a life expectancy less than 1 year 7. history or evidence of drug or alcohol abuse within the last 12 months 8. any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study 9. history of hypersensitivity to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs. 10. latex allergy 11. history of noncompliance to medical regimens or unwillingness to comply with the study protocol 12. use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer positive pregnancy test, breast feeding women or women of child bearing potential not using highly effective methods of contraception. 13. patients who are also taking strong cyp3a4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir) 14. patients taking antiplatelet medications which cannot be stopped 15. severe liver disease

Keywords: coronary artery disease endothelial function antiplatelet agent
impact of digital therapeutic on metabolic parameters

Conditions: Insulin Resistance; Prediabetic State; Diabetes Mellitus, Type 2; Obesity

Summary: the purpose of this prospective randomized controlled study is to evaluate the impact of a six-month digitally administered behavioral change program on body weight, glycemic control and other metabolic parameters in obese adults with insulin resistance, prediabetes or type 2 diabetes as compared to conventional high-intensity lifestyle intervention program administered at a specialized department of a university hospital.

in this prospective randomized clinical study, obese adults with insulin resistance, prediabetes or diabetes mellitus type 2, patients of the department of exercise medicine and cardiovascular rehabilitation at the university hospital olomouc, are randomized to receive either vitadio or a conventional 6-month high-intensity lifestyle intervention program at the clinic. vitadio is a mobile application delivering behavioral change program focused on lifestyle change and self-management. the program aims for strengthening patients autonomy with the goal to promote weight loss and improve metabolic health. the program includes personalized education, adaptive daily tasks and weekly goals, automated motivational and educational messaging, monitoring tools, recipes, peer-support group and one-on-one remote coaching. personalization of the intervention is achieved by analyzing participant's interactions with the application. the conventional therapy consists of 5 face-to-face nutrition/lifestyle education sessions (at baseline, at 1st, 2nd and 3rd month, and at month 6). participants in the control group can use an online diary tool for recording meals with an option to receive remote feedback on their diet from the educator. in addition, all participants undergo a regular medical assessment at the clinic (baseline, month 3, month 6). the aim of the study is to assess feasibility and efficacy of digitally administered intervention by comparing evolution of weight, physical fitness, laboratory measures of metabolic health, blood pressure and other outcomes.

Eligibility criteria:
inclusion criteria: * obesity with body mass index (bmi) above 30 kg/m\^2 * insulin resistance or prediabetes or type 2 diabetes mellitus * acess to device with internet access (notebook, smartphone, tablet) * willingness and ability to comply with all scheduled visits, laboratory tests, lifestyle considerations and other study procedures exclusion criteria: * pregnancy * steroid treatment * type 2 diabetes mellitus on insulin therapy * severe renal and/or hepatic impairment * any impairments including mental and psychological or conditions which, in the opinion of the investigator, would seriously compromise the integrity of the study * inability to understand, consent to, or comply with the study protocol for any reason, including inability to read or comprehend czech language * inability to comply with study procedures
a confirmatory trial of sk-pc-b70m in mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of sk-pc-b70m in patients with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of probable alzheimer's disease(dsm-iv and nincds-adrda criteria) * mri within the last 12 months consistent with a diagnosis of ad * mmse score of 10 to 26 and cdr of 1 or 2 * achei or memantine was not taken at least 3 months prior to screening exclusion criteria: * other central nervous disease * hypothyroidism, vitamin b12/ folic acid deficiency, hypercalcemia, neurosyphilis, aids * t.i.a or major infarction within the last 12 months * any serious disorder that could limit the ability of the patient to participate in the study * copd or asthma * any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study
intra-articular, single-shot injection of hyaluronic acid and corticosteroids in knee osteoarthritis

Conditions: Osteoarthritis; Pain Syndrome; Intra-articular Injection

Summary: the aim of present study is to to investigate whether the combined injection of ha and cs was superior than ha alone in the treatment of knee oa.

intra-articular injection of hyaluronic acid (ha) or corticosteroids (cs) has been widely used with debate on its efficacy in osteoarthritis (oa). the aim of present study is to to investigate whether the combined injection of ha and cs is superior than ha alone in the treatment of knee oa.

Eligibility criteria:
inclusion criteria: according to radiographic findings, patients who are suffering from knee oa for over 3 months have to be stage ii-iv according to the kellgren-lawrence (kl) grade by a senior radiologist. the diagnosis of symptomatic knee oa is based on american rheumatism association classification criteria for knee osteoarthritis. exclusion criteria: exclusion criteria are the diagnosis of rheumatoid arthritis or other inflammatory oa, presence of trauma or pain-causing diseases, treatment with oral medications in recent 3 days, physiotherapy and intra-articular injection of ha or cs in the past 6 months. participants who are allergic to any of the medications used in this study or diagnosed with current systemic infection are also excluded.
artificial intelligence-powered virtual assistant for emergency triage in neurology

Conditions: Stroke; Guillain-Barre Syndrome; Facial Palsy; Migraine; Status Epilepticus; Vertigo Benign Positional; Delirium; Trigeminal Neuralgia; Meningitis; Subarachnoid Hemorrhage

Summary: this study examines the use of an ai-powered virtual assistant for quickly identifying and handling neurological emergencies, particularly in places with limited medical resources. the research aimed to check if this ai tool is safe and accurate enough to move on to more advanced testing stages. in a first-of-its-kind trial, the virtual assistant was tested with patients having urgent neurological issues. neurologists first reviewed the ai's recommendations using clinical records and then assessed its performance directly with patients. the findings were as follows: neurologists agreed with the ai's decisions nearly all the time, and the ai outperformed earlier versions of chat gpt in every tested aspect. patients and doctors found the ai to be highly effective, rating it as excellent or very good in most cases. this suggests the ai could significantly enhance how quickly and accurately neurological emergencies are dealt with, although further trials are needed before it can be widely used.

background and objectives: neurological emergencies pose significant challenges in medical care, especially in resource-limited countries. artificial intelligence (ai), particularly health chatbots, offers a promising solution. however, rigorous validation is required to ensure safety and accuracy. the objective of our work is to evaluate the diagnostic accuracy and resolution effectiveness of an ai-powered virtual assistant designed for the triage of emergency neurological pathologies, to ensure the minimum standard of safety that allows for the progression to successive validation tests. methods: this phase 1 trial evaluates the performance of an ai-powered virtual assistant for emergency neurological triage. ten patients over 18 years old with urgent neurological pathologies were selected. in the first stage, nine neurologists assessed the safety of the virtual assistant using their clinical records. in the second part, the assistant's accuracy when used by patients was evaluated. finally, its performance was compared with chat gpt 3.5 and 4.

Eligibility criteria:
inclusion criteria: * patients over 18 years old consulting in the er due to a neurological emergency exclusion criteria: * pregnancy
appraising medical trial experiences of ovarian cancer patients

Conditions: Ovarian Cancer

Summary: historically, participation in clinical trials has been highly skewed towards specific demographic groups. however, research identifying which trial attributes impact participation, in either positive or negative ways, is limited. this study invites participants to record a wide range of data on their clinical trial experience, with the goal being to identify factors which persistently limit patients' ability to participate in, or complete, a trial in which they were initially interested. data will be analyzed through a range of demographic lenses, in hopes of discovering patterns which might improve the experience of future ovarian cancer patients.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed * patient has been diagnosed with ovarian cancer * subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination. exclusion criteria: * inability to perform regular electronic reporting * patient does not understand, sign, and return consent form * pregnant, breastfeeding or expecting to conceive within the projected duration of the study

Keywords: ovarian cancer
correlation and comparison of the hepquant® disease severity index (dsi) with hepatic venous pressure gradient (hvpg)

Conditions: Liver Disease

Summary: this study plans to learn more about a new test to look at liver function, the hepquant-shunt (hq-shunt). the hq-shunt is being evaluated for safety and effectiveness as an alternative to hepatic venous pressure gradient testing in patients with liver disease.

the goal of this study is to demonstrate the hq-shunt is safe, simple to administer, noninvasive, cost-effective, and well tolerated by patients. this study will compare the hq-shunt to hepatic venous pressure gradient (hvpg) testing. in this study, 100 consecutive patients with various etiologies of liver disease who have undergone technically successful hvpg testing as standard of care will also undergo hq-shunt testing.

Eligibility criteria:
inclusion criteria: * liver disease patient scheduled to have an hepatic venous pressure gradient (hvpg) procedure * at time of enrollment, being between the ages of 18 and 75 exclusion criteria: * concomitant treatment with both a beta blocker and an ace inhibitor * concurrent hepatic malignancy. patients with a history of treated hcc can be included if there is no evidence of recurrent disease at the time of this study. * unstable angina or history of myocardial infarction or congestive heart failure within 6 months prior to enrollment into this study * renal insufficiency with chronic kidney disease stage 4 or 5 (gfr \< 30 ml/min/1.73m2) * crohn's disease or any active intestinal inflammatory condition * having had an ileal resection * diabetic gastroparesis * pregnancy or intent to become pregnant. urine pregnancy tests will be performed prior to hq shunt testing. * inability to consent for one's self

Keywords: hepatic venous pressure gradient (hvpg) testing hepquant-shunt liver function
a single-arm phase 2 study with optimized standard protocol for severe aplastic anemia

Conditions: Aplastic Anemia

Summary: severe acquired aplastic anaemia (saa) is a bone marrow failure disease characterized by pancytopenia and a hypocellular bone marrow. the corn pathophysiological mechanism is the destruction of hematopoietic stem/progenitor cells mediated by auto-reactive effector t cells. immunosuppressive therapy with horse antithymocyte globulin (atg) plus cyclosporine (csa) is currently the standard of treatment in patients with aplastic anaemia who are not eligible for bone marrow transplantation and with response rates from 40% to 70%. previous studies showed that horse atg (hatg) is apparently more effective than rabbit atg (ratg) as the latter has higher treatment related mortality (trm). unfortunately hatg is unavailable in china, so we conduct a optimized standard treatment (9 days protocol) of ratg plus csa and levamisole (lms) sequential maintaining (termed optimized standard protocol, osp) for severe aplastic anemia. this prospective study is designed to evaluate the efficacy and safety of optimized standard protocol as first line therapy in newly diagnosed severe aplastic anemia patients.

during the treatment period, ratg is administered at a dose of 1.97 mg/kg/day for 9 days by slow intravenous infusion. csa is administered orally at a dose of 3 mg/kg qod, and levamisole was administered orally at a dose of 2.5 mg/kg qod. the csa and levamisole (lms) is designed to alternately every other day.

Eligibility criteria:
inclusion criteria: * newly diagnosed saa (according to the standard criteria) 1. bone marrow cellularity less than 30% (excluding lymphocytes) 2. at least two of the following: absolute neutrophil count less than 500/ ul; platelet count less than 20,000/ ul; absolute reticulocyte count less than 20,000/ ul. * age greater than or equal to 6 years old exclusion criteria: * serum creatinine greater than 2.5 mg/dl * underlying carcinoma (except local cervical, basal cell, squamous cell) * prior immunosuppressive therapy with atg, antilymphocyte globulin (alg), or high dose cyclophosphamide. * current pregnancy or lactation or unwillingness to take oral contraceptives or use an effective method of birth control. * diagnosis of fanconi anemia or other congenital bone marrow failure syndromes * evidence of a clonal disorder on cytogenetics. patients with super severe neutropenia (anc less than 200/ul) will not be excluded if results of cytogenetics are not available or pending. * underlying immunodeficiency state including seropositivity for hiv * inability to understand the investigational nature of the study or give informed consent * moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient s ability to tolerate protocol therapy, or that death within 7-10 days is likely.

Keywords: saa immunosuppressive treatment atg cyclosporine levamisole
pharmacological treatment on the recovery of neurosensory disturbance after bilateral sagittal split osteotomy

Conditions: Retrognathism; Prognathism; Orthognathic Surgery; Neurosensory Disorder

Summary: the bilateral sagittal split osteotomy (bsso) of the mandible is one of the most used surgical techniques to achieve a harmonious jaw relation in the context of orthognathic surgery. nevertheless, one of its main complications is neurosensory damage to the inferior alveolar nerve, which can cause severe impact in the quality of life on patients who suffer from it permanently. the purpose of this randomized clinical trial is to provide rigorous scientific evidence of the pharmacological effect of 1) melatonin, 2) combination uridine triphosphate (utp), cytidine monophosphate (cmp), and hydroxycobalamin (utp/cmp/hydroxycobalamin) and 3) hydroxycobalamin regarding neurosensory disturbances incidence and persistence after bsso.

the study will be done according to the international standards of the helsinki convention for medical research and approved by the scientific ethics committee of universidad de los andes clinic. all subjects will give their signed consent to participate of this clinical research. this clinical randomized trial will be double-blinded as both the patient and the surgeon will not know the treatment used until the experiment is over. the randomization will be done using "random.org" software to assign participants into 4 groups. groups a, b and c will receive the medication, whereas the group p will receive a placebo.

Eligibility criteria:
inclusion criteria: patients with dentomaxillofacial anomalies who present a complete mandibular dental arch and who have not undergone previous mandibular surgery. exclusion criteria: patients who: * do not have sufficient information in their clinical records * cannot be contacted * do not attend their check-ups (for at least 24 postoperative months in cases with dns) * have refused consent to the use of their information for purposes of research. * already undergoing orthognathic surgery * with systemic conditions prone to alter recovery patterns or serious systemic diseases (decompensated metabolic disorders; neoplasms; osteodysplasias; neuropathies). * pregnancy

Keywords: bilateral sagittal split osteotomy neurosensory disturbances